Congenital Heart Defects and NIRS

Heart Defects, Congenital Clinical Trial

Official title:

Tissue Oxygenation in Newborns With Congenital Heart Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411512
• Other study ID #: NIRS CHD1
• Status: Completed
• Phase: N/A
• First received: January 19, 2018
• Last updated: January 26, 2018
• Start date: December 1, 2012
• Est. completion date: May 31, 2014

Study information

• Verified date: January 2018
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Congenital Heart Defects and NIRS

Description:

Brain, kidney and intestinal tissue oxygenation in newborns with congenital heart defects assessed by near-infrared spectroscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 31, 2014
• Est. primary completion date: April 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

Inclusion Criteria:

Investigators included term newborns with critical structural CHD (of different types) who required surgical or transcatheter procedure in the first year of life. CHD were diagnosed by pediatric cardiologist by clinical examination and echocardiography.

Exclusion Criteria:

The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Petja Fister, MD, PhD

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rSO2	regional tissue oxygenation assessed by NIRS	RSO2 values were obtained after 30 minute calm down period to enable stable recordings on each channel by averaging five minutes recorded values.